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Kite is hiring a

Senior Quality Engineer

Aalsmeer, Netherlands

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Job Description

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Job Description

As a Senior Quality Engineer, you’ll be joining a team in which people of diverse backgrounds and experiences are respected and are working together focused on saving lives by finding the cure for cancer. You will report to the Director Engineering of the manufacturing plant in Hoofddorp (TCF04).

Your profile

  • Support enterprise, cross functional and local computer systems validation activities, in providing approach, methodology and deliverables in compliance with GMP, 21 CFR Part 11, EU Annex 11 and Data Integrity.

  • Provide Quality oversight, inputs and quality approvals for validation documents and help to ensure Quality, Data integrity and compliance of TCF04 IT/OAT systems.

  • Partners with and maintains alignment between IT/OAT (Operations Automation Technology) and BPQ's (Business Process Owner) and end users for the delivery and maintenance of IT systems/automation for the site.

  • Reviews and approves documents, change controls, and protocols related to IT/OAT systems (site and global).

  • Ensures the application of data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.

  • Represents Quality for TCF04 throughout the initiation and implementation of projects related to electronic systems/automation.

  • Ensure that GMP computer systems meet intended uses and comply with applicable regulations, current industry practices, and Kite policies and procedures. CSV projects will include manufacturing and lab systems, and steady state activities around these systems and its applications.

  • Develop validation documents (Validation plan, Qualification and UAT plans and test cases, Traceability Matrix, and Validation Summary Reports) with functional teams, ensuring the documentation meets compliance requirements and quality standards.

  • Drive continuous process improvement in computer system validation.

  • Support the team in CQV quality oversight activities and Quality Risk Management oversight activities for the site (in house training will be provided)

Your new role

  • BSc degree in Engineering, Computer Science to relevant scientific field.

  • Previous experience in FDA/EU regulated environment with good understanding of GxP standards, Risk based validation and cGMP manufacturing for biotech/pharmaceuticals.

  • Knowledge of EU and FDA guidance’s, regulatory regulations, and industry standards on computerized systems in pharmaceutical industry

  • (i.e., Quality Systems, GAMP5, 21CFRPart11 and EudraLex Volume 4 Annex 11).

  • Experience with the creation, review, and execution of qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of non-conformances /deviations. Experience with Computer System Assurance (CSA) in CSV is a plus

  • Experience with electronic validation software (e.g., Valgenesis, HPALM, KNEAT) is a plus

  • Experience in CQV and Quality Risk Management is a plus

Your soft skills

  • Ability to think critically and utilize troubleshooting and problem-solving skills.

  • Self-motivated and willing to accept temporary responsibilities outside of initial job description.

  • Well-developed computer skills and fluent with Microsoft office applications.

  • Excellent interpersonal, verbal, and written communication skills and ability to work in collaborative and fast paced work environment.

  • Comfortable in a fast-paced company and ambiguous environment

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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